MCW
Auryon Atherectomy System
- Advisory panel
- Cardiovascular
- Total cleared
- 146
Adverse events under product code MCW
product code MCW- Death
- 38
- Injury
- 1,386
- Malfunction
- 2,676
- Other
- 2
- Total
- 4,102
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code MCW
1–100 of 146- K260244 — Auryon Atherectomy System
- K250723 — FreedomFlow Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration)
- K250385 — Turbo-Elite Laser Atherectomy Catheter
- K242757 — Rotarex Atherectomy System
- K242947 — FreedomFlow Orbital Circumferential Atherectomy System
- K241553 — Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic Coating
- K233483 — FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration)
- K233668 — Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating (EXM-4010-H000), Auryon Atherectomy Catheter 0.9 mm XL, Hydrophilic Coating (EXM-4011-H000), Auryon Atherectomy Catheter 1.5 mm XL (EXM -4010-0000), Auryon Atherectomy Catheter 0.9 mm XL (EXM-4011-0000)
- K231538 — FreedomFlow Orbital Circumferential Atherectomy System
- K230709 — Auryon Atherectomy System
- K230005 — Pantheris LV Atherectomy Catheter
- K222837 — Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters
- K220116 — Auryon Atherectomy Catheters
- K220962 — ROTAPRO Rotational Atherectomy System
- K221077 — Auryon Atherectomy System
- K220568 — Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System, Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series
- K220109 — DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System
- K212351 — Revolution Peripheral Atherectomy System
- K212047 — Pantheris System
- K210586 — Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital Atherectomy system
- K211738 — Rotarex Atherectomy System
- K212027 — TurboHawk Plus Directional Atherectomy System
- K211518 — 2.4mm X 130cm Phoenix Deflecting Atherectomy System, 1.5mm X 149cm Phoenix Atherectomy System
- K202835 — Auryon Atherectomy System
- K203008 — DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System
- K191419 — Revolution Peripheral Atherectomy System, Revolution Peripheral Atherectomy Guidewire
- K190634 — Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System
- K182341 — Pantheris SV
- K182972 — Phoenix Atherectomy System
- K181877 — Phoenix 2.4mm Atherectomy Plus System
- K182397 — Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series
- K181642 — B-Laser Atherectomy System
- K173862 — Pantheris System
- K180416 — ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD), DIAMONDBACK 360 Peripheral Atherectomy System
- K172315 — Straub Endovascular System
- K180694 — Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters
- K172687 — Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters
- K172236 — Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox Sled
- K172386 — 1.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy System, 2.4mm X 130cm Phoenix Atherectomy System
- K170191 — SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System
- K170792 — Diamondback 360 Peripheral Orbital Atherectomy System
- K170059 — Spectranetics Turbo-Elite Laser Atherectomy Catheters
- K162561 — Turbo-Power (2.0mm) Laser Atherectomy Catheters
- K163264 — Pantheris Catheter (8F); Pantheris Cather (7F); Lightbox HS Imaging Console; Lightbox Sled
- K162326 — Pantheris Catheter, Lightbix HS Imaging Console, Lightbox Sled
- K161361 — HawkOne Directional Atherectomy System
- K160827 — Pantheris Catheter
- K153460 — Pantheris Catheter (8Fr), Pantheris Catheter (7Fr)
- K152181 — Turbo-Power Laser Atherectomy Catheter
- K152694 — Diamondback 360 Peripheral Orbital Atherectomy System
- K152275 — Pantheris System
- K151260 — ViperWire Advance Guide Wire, Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Orbital PAD
- K151145 — 2.4mm X 127 cm Phoenix Atherectomy Deflecting System
- K150732 — Diamondback 360 Peripheral Orbital Atherectomy System
- K143328 — 1.8mm X 149 cm Phoenix Atherectomy Catheter, 2.2mm X 149 cm Phoenix Atherectomy Catheter, Phoenix Handle, Phoenix Wire Support Clip
- K141801 — HAWKONE DIRECTIONAL ATHERECTOMY SYSTEM
- K133023 — JETSTREAM XC 2.4/3.4; JETSTREAM XC 2.1/3.0; JETSTREAM SC 1.85; JETSTREAM SC 1.6
- K140944 — 1.8 MM PHOENIX ATHERECTOMY CATHETER, 2.2 MM PHOENIX ATHERECTOMY CATHETER, PHOENIX HANDLE, PHOENIX WIRE SUPPORT CLIP
- K140775 — TURBO-ELITE ATHERECTOMY CATHETERS, TURBO TANDEM SYSTEM
- K133999 — DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
- K132682 — PHOENIX 5F TRACKING ATHERECTOMY CATHETER, PHOENIX 6F TRACKING ATHERECTOMY CATHETER, PHOENIX 7D DEFLECTING ATHERECTOMY CA
- K133566 — ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH THE PERIPHERAL ROTALINK PLUS
- K133399 — DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
- K131092 — STEALTH 360 ORBITAL PAD SYSTEM
- K130637 — JETSTREAM XC 2.4/3.4 SYSTEM; JETSTREAM XC 2.1/3.0 SYSTEM; JETSTREAM SC 1.85 SYSTEM; JETSTREAM SC 1.6 SYSTEM
- K123632 — 2.5MM TURBO ELITE 035, 2.3MM TURBO ELITE 035
- K122987 — STEALTH 360 ORBITAL PAD SYSTEM
- K122916 — JETSTREAM NAVITUS L SYSTEM JEYSTREAM NAVITUS SYSTEM JETSTREAM G3 SF SYSTEM JETSTREAM SF 1.6 SYSTEM
- K121774 — ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH PERIPHERAL ROTALINK PLUS
- K120346 — CLEANER ROTATIONAL THROMBECTOMY SYSTEM
- K120242 — JETSTREAM NAVITUS L SYSTEM
- K111723 — TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM
- K111388 — DIAMONDBACK 360* ORBITAL ATHERECTOMY SYSTEM, STEALTH 360* ORBITAL PAD SYSTEM
- K111229 — JETSTREAM G3 (R) SF 1.6 SYSTEM
- K110626 — JETSTREAM NAVITUS SYSTEM; JETSTREAM G3 SF SYSTEM; JETSTREAM G3 SE SYSTEM; JETSTREAM G3 L SYSTEM
- K110389 — STEALTH 360 ORBITAL PAD SYSTEM
- K103618 — TURBOHAWK PEROPHERAL PLAQUE EXCISION SYSTEM
- K101334 — JETSTREAM G3 SE SYSTEM, JETSTREAM G3 SF SYSTEM MODEL PV31230 (JETSTREAM G3 SE CATHETER AND CONTROL POD); PVCN100 (PV CON
- K101221 — JETSTREAM G3 SYSTEM, MODEL PV31300, PV CONSOLE, MODEL PVCN100
- K100462 — JETSTREAM G3 L SYSTEM, PV CONSOLE, MODELS PV31400, PV31300, PVCN100
- K091029 — CLEANER ROTATIONAL THROMBECTOMY SYSTEM (9 MM X 65 CM) AND (9 MM X 120 CM)
- K094036 — TURBO-TANDEM SYSTEM MODEL 472-110
- K093918 — JETSTREAM G3 L SYSTEM MODEL PV31400 (JETSTREAM G3 L CATHETER WITH CONTROL POD); PVCN100 (PV CONSOLE)
- K093456 — JETSTREAM G3 SYSTEM
- K093301 — TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM
- K092332 — JETSTREAM G3 SYSTEM, MODEL PV31300 ( JETSTREAM G3 CATHETER AND CONTROL POD)., PVCN100 (PV CONSOLE)
- K091509 — JETSTREAM G2 NXT SYSTEM, MODEL PV20300
- K090521 — DIAMONDBACK 360 DBX
- K090325 — JETSTREAM G2 SYSTEM, MODELS PV20300 (JETSTREAM G2 CATHETER AND CONTROL POD); PVCN100 (PV CONSOLE)
- K083489 — JETSTREAM PATHWAY PC ATHERECTOMY SYSTEM, MODEL OV10300
- K083837 — JETSTREAM G2 SYSTEM, MODELS PV20300 (JETSTREAM G2 CATHETER AND CONTROL POD); PVCN100 (PV CONSOLE)
- K082981 — DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM WITH VIPERSLIDE LUBRICANT
- K082664 — JETSTREAM PATHWAY PV ATHERECTOMY SYSTEM, MODEL PV10300, PVCN100
- K082186 — MODIFICATION TO PATHWAY PV ATHERECTOMY SYSTEM
- K081944 — MODIFICATION TO DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM
- K081328 — PATHWAY PV ATHERECTOMY SYSTEM
- K071432 — SILVERHAWK-R PERIPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE
- K072748 — MODIFICATION TO: DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM
- K072800 — DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM
- K071427 — DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS
Data sourced from openFDA. This site is unofficial and independent of the FDA.